?? Collaborations for hypothermia research ??

1. ?? Collaborations for hypothermia research ?? Target disorder Different technologies Treatment protocols Basic/translational/clinical

2. The NIH Roadmap: Four themes emerged • Revolutionary Methods of Research • New Pathways to Discovery • Multi-disciplinary Research Teams of the Future • Re-engineering the Clinical Research Enterprise

3. Collaborations • Why do it? Sum of the parts…. What NIH does: • Disease specific (SPORs, SCORs, etc.) • Investigator-initiated: P50, P01 • Clinical trials “networks” • Large clinical trials

4. Bioengineering Research Partnerships • PAR-03-032 expires August 23, 2003 • Trans-NIH • Technology plus biological system • Hypothermia: Lance Becker, NHLBI

5. National Institute of General Medical Scienceswww.nigms.gov • Integrative and collaborative approaches to research • Must involve investigators at different institutions and must introduce new collaborative and interactive activities • $300,000 • GLUE grants • Much larger • Not available in 2003; ???? 2004

6. Specialized Program of Translational Research in Acute Stroke • PAS-01-092 P50 mechanism • Establish a network of centers: 3 centers now • Collaboration between EMS, ED, Neurology, Radiology • Phase I trial of endovascular hypothermia w/wo tPA (Patrick Lyden at UCSD)

7. NINDS Initiative in Translational Research • NINDS Cooperative Program in Translational Research (PAR-02-139) • NINDS Institutional Center Core Grants to Support Neuroscience Research (PAR-02-059)

8. NINDS Cooperative Program • Translational Research Conferences(U13) • Single-Component Translational Research Projects (U01) • Multi-Component Translational Research Projects (U54) • 5 years; negotiate budget$; milestones; involve NINDS program directors

9. Clinical trials are collaborations • Field Administration of Stroke Treatment - Magnesium (FAST-MAG) Trial: A Randomized, Double-Blind, Placebo Controlled Trial of Neuroprotective Magnesium Sulfate Therapy for Acute Stroke Administered Within 2 Hours of Onset by Paramedics in the Field • UCLA Stroke Center; USC Department of Emergency Medicine; Los Angeles County Fire Department Paramedic System; Los Angeles City Fire Department Paramedic System • R01, 1 PI

10. Priorities for Clinical Collaboration • Follow a good pre-clinical lead • Timing/duration of target mechanism • Timing/duration of intervention • Mechanism exists in human disease • Outcome measures show an effect • Patients available

11. Trials in Consortia • Phase I/II and NINDS Pilot trials • Fixed sample size • Staged designs • Selection trials • NOTunderpowered Phase III • Phase III: Outcomes clinically meaningful Types of trials

12. Brain injury • Mechanisms complex and interrelated • Timing may be unique • Injuries heterogenous • Individual differences among patients • Multiple therapies or staged therapy

13. Conferences to assess a field Expert recommendations often include formation of groups to tackle specific problems or development of guidelines. • NHLBI workshops • PULSE (post-resuscitation & initial utility in life saving efforts) • Neurocognitive outcome after CABG • Working group on trauma research • NINDS • Clinical trials in brain injury

14. Consensus needed? • Methods of hypothermia • Intervention parameters • Disorders to be treated: Patient characteristics • ? Preventing hyperthermia • Additional therapies • Comparability among trials

15. Advantages Results quicker Compare results Educate investigators Raise standard of care or state-of-the-art Do the BIG experiment Disadvantages Expense Logistics Personnel intensive Locked-in syndrome Who’s in charge? Flexibility limited Collaborations

16. con·sen·sus:opinion/position reached by a group as a whole or by majority will. General agreement or accordcon·sor·ti·um: association or combination…for the purpose of engaging in a joint venture. A cooperative arrangement among groups or institutionscol·lab·o·rate: to work together, especially in a joint intellectual effort